Manufacturers’

serialisation challenges

with FMD & DR

implementation

Mike Rose

Vice President, Supply Chain Visibility, Johnson & Johnson Supply Chain

Chairman of EFPIA’s Supply Chain WG & FMD ImplementationWG

9 November 2017

Quality aspects of coding &

serialisation - following

the code end to endAssumptions: Codes are printed online, there’s no

aggregation

2

Pro

cess

Ste

p

Master Data & Artwork

management

Process Order Created Start-up of packing line Pack Produced

Da

ta f

low

Po

ints

to

co

nsi

de

r

Defined and appropriate areas for

the required print

Consider space needed for multi-

market packs. Consider pre-printed

HRI* for GTIN**, NHRN*** and

prefixes

Blue box for centrally authorized

products (multimarket packs - one or

more codes?)

* HRI = Human Readable Information

** GTIN = Global Trade Item Number

*** NHRN = National Healthcare Reimbursement

Number

Verify correct master data

availableVerify 2D barcode and human

readable text

Commission (associate pack &

serial number)

Ensure sufficient amount of numbers

available at line including additional

quantity for rejects

Interface to CMO (eg. send number

series or CMO creates serial

numbers…)

* CMO = Contract Manufacturing Organization

Check code and HRI print quality,

content and readability before

start up

Ensure IPC* include coding &

serialisation aspects

Include information other than the

unique identifier in the 2D barcode,

eg. 6th data element’ per Art. 8

* IPC = In Process Controls

100% check or IPC of 2D code

quality, content & readability

100% OCR* or IPC presence control

for HRI text and print quality

* OCR =Optical Character Recognition

Create randomised number series Download data elements to the

line

In Lot re-packing

Decommission serial numbers

Apply new serial numbers

Note: A portable scanner or mobile

workstation might be an option to be

able to remove the part to be

repacked from the lot

Re

f DR Art. 5, 6, 7 DR Art. 4 DR Art. 8 DR Art. 5, 6, 14 DR Art. 16, 17

Directive 2001/83/EC Article 47a

Quality aspects of coding &

serialisation - following

the code end to endAssumptions: Codes are printed online, there’s

no aggregation

3

Order Complete Quality Released Quality Certified

Upload serial numbers from

packing line to company database

Reconcile codes, report as part of

batch record

QA review & release

Ensure at least as many codes as

packs

Establish a threshold for the positive

difference with justification based on

capability and trends

QA check or IPC if this has been

taken place properly, e.g. data

consistency and integrity and

manage any deviations

Batch document check. Print quality

ok? Reconciliation ok? Tamper

evidence ok?

Production order serial number data

set uploaded to company database?

Any damages or in-lot re-work must

include actions for code / data

handling

Define who is responsible for upload

*Article 33, 1st paragraph states “the

information is uploaded in the

repositories system before the medicinal

product is released for sale or

distribution”.

Note: The optimal point of data upload

might be later in the process to avoid

different processes for aggregated and

non aggregated goods

QP certification

Data upload to EU Hub*

Confirmation of data upload to EU /

national Hub

Pro

cess

Ste

pD

ata

flo

wP

oin

ts t

o c

on

sid

er

Picked, packed, shipped

and free samples

Free Samples per Art. 41

Goods for special customers per Art. 23

Export: EU labelled goods for non-EU markets (Packing

orders originally intended for non-EU markets do not need

upload of codes) per Art. 12

Investigational products intended for clinical trials per Art.

16

Note: Any repacking activity after Quality certification must

still comply with the regulation (keep or replace code)

Art 33.1 states that “the person responsible for placing

medicinal products on the market shall ensure… that the

repositories is kept up to date thereafter”

Decommission codes for special reasons

Re

f

EudraLex Volume 4, EU GMP Guidelines

Annex 16: Certification by a Qualified Person

and Batch Release of 12 October 2015

DR Art. 33, 38 DR Art. 10, 11, 12, 16, 19, 20, 21, 22, 23, 33, 41

Where a manufacturer distributes his products by wholesale, Article 20(a), and Articles 22,

23 and 24 shall apply to him in addition to Articles 14 to 18.

Quality aspects of coding

& serialisation -

following the code end to

endAssumptions: Codes are printed online, there’s

no aggregation

4

Recalled, withdrawn or

stolen product

Ensure decommissioning of the unique

identifier of recalled / withdrawn

product

Ensure decommissioning of unique

identifier of recalled / withdrawn /

stolen product where known (not always

the case)

Note: Suggested principle is that the supply

chain actor that initiate an action ensures

updates to the hub

In case of tampering or suspected

falsification immediately inform the relevant

competent authorities

Ensure decommissioning of unique

identifiers

Pro

cess

Ste

pD

ata

flo

wP

oin

ts t

o c

on

sid

er

Destroyed productReturned product

Authenticity must be verified by

checking the serial number status

against the EU HUB

Products which cannot be

reverted to an active status

shall not be returned to

saleable stock

For products intended for

destruction authenticity must be

verified and the UI* must be

decommissioned

* UI = Unique Identifier

Verify authenticity of and

decommission code

Verify authenticity and integrity

Any damages or sampling post QA release must include

actions for code / data handling

At end of shelf-life system will automatically change status to

unavailable

Ensure harmonization of common data elements for IDMP

and EMVS – look for efficiency opportunities

Ensure harmonization of prefixes / expiry date format (per

GS1 standard YYMMDD)

Reconciliation and reporting requirements are unclear (at

which point in the process?)

Impact of alerts / flags from the EU hub and any enquiries

from data transactions

Handling of customer complaints e.g. from pharmacies if

issues with reading of codes

Handling of customer complaints e.g. from pharmacies if

issues with tampering

Timelines for transition from linear bar codes (OK with

different product identifiers during transition?)

Ensure that the information is uploaded to the repositories

system before the medicinal product is released for sale or

distribution by the manufacturer (see comment on previous

slide), and that it is kept up to date thereafter

General points to consider

Re

f

DR Art. 12, 22(c), 40DR Art. 20, 22(b)DR Art. 18, 40

Complexity Drivers• The use of a 2D barcode and International Standards has helped to simplify FMD deployment.

• However, there are other topics which will drive unnecessary complexity and cause issues with FMD implementation if not addressed, these are:

• Human readable text order

• Prefix (heading) location

• Use of labels to apply coding

• Barcode transition requirements post Feb 2019

• Encoded data order within the 2D barcode

• Application identifier use

• Printed format of the 2D Data Matrix

• EFPIA, Medicines For Europe and the EAEPC are working on a set of advocacy documents on these topics and calling for clarification within version 8 of the Q&A document and harmonisation of requirements across the EU.

Some examples of complexity

drivers

Human readable text order

Use of Stickers/ labels

2D Data Matrix Format

GS1 - GTIN

Austria*, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark**,

Estonia, Finland**, Germany*, Hungary, Iceland**, Ireland, Latvia,

Lithuania, Malta, Netherlands, Norway**, Poland**, Portugal, Romania,

Slovakia, Slovenia, Spain**, Sweden, Switzerland, UK

* GTIN for multi country - shared packs

** Some countries will allow GTIN or NTIN

GS1 - NTIN

Austria*, France, Germany*

* For market specific packs

TBC

Italy and Greece (coding requirements under discussion)

Some countries (outlined in red) also require a national number in the 2D

Barcode when using GTIN

Harmonisation has increased, but . . . Harmonisation has increased, but . . . Harmonisation has increased, but . . . Harmonisation has increased, but . . . • To date there have been a number of important decisions made which help

harmonise the FMD implementation across Europe:

– Choice of data carrier (2D DataMatrix)

– Choice of coding scheme (ability to use International standards such as GS1)

Next Steps

• It is vital we resolve the coding and labelling issues

• To do this we URGENTLY need:

• National Competent Authorities formally and unambiguously clarify the coding requirements which are applicable in their country

• Alignment across countries (due to issues such as shared packs & movement of good, etc)

• Without formal confirmation companies cannot kick off the serialisation activities and continue to prepare to meet the FMD deadlines

• EMVO stakeholders would welcome a joint response from Commission and National Competent Authorities on the various coding and labelling issues identified

Further clarification could be addressed in Version 8 of the Commission Q&As

Further clarification could be addressed in Version 8 of the Commission Q&As

Background SlidesNot for presentation purposes but can circulated

Human readable text order and Prefix (heading) location• Complying with a specific order and layout for the data elements is not achievable due to physical, technical and other regulated requirements.

• We also can not comply with a specific order where the data is split over several faces of the pack, which is allowed by the DR, art 7(3)

• The order of these data elements does not impact on patient safety or usability of the product as long as the information is clearly laid out and legible.

• It may not always be possible to locate the headers for the human readable data elements beside the elements themselves but instead follow current common practice of locating these near to the data elements.

• Recommend that the answer to question 2.10 of the Commission Q&A document (version 7) is updated and no specific order recommended

• Clarification added to the Q&A that the headers can be located beside or near to the data elements

The layout of the elements should not follow a specific order and header location should follow current common practiceThe layout of the elements should not follow a specific order and header location should follow current common practice

Use of stickers/ labels to apply coding• Stickers/ labels are permitted today and are currently used on many types of product packaging

• Examples include:

• Stickers/ Labels on bundles

• Stickers/ Labels on large format packs

• Stickers/ Labels on bottles where there is no outer carton/box

• Stickers/ Labels on plastic packs

• Stickers/ Labels used during re-packaging operations

• They also offer a cost effective method of applying the Unique Identifier where re-packaging or re-boxing are the only other alternative

This image cannot currently be displayed.

Manufacturers should have the choice to use labels/ stickers to apply the Unique Identifier and human readable text if they wish

Manufacturers should have the choice to use labels/ stickers to apply the Unique Identifier and human readable text if they wish

Barcode transition requirements

• Until Feb 2019 there is no obligation for the 2D DataMatrix to be scanned. For this reason the old linear barcodes need to be kept

• After Feb 2019,

• MAHs may want to remove the linear barcode for some products remove unnecessary information

• For other products, there might be a need to keep the linear barcode for packs which are shared e.g. Cyprus/Greece, Romania/ Macedonia

• Country specific or EU-wide obligations to have the linear barcode removed by 9-Feb-2019 or thereafter should be avoided.

• Decision to keep or remove the linear barcode should be at the discretion of the MAH.

• If MAH decides to remove linear barcode, it should not require a regulatory procedure.

• EMA and CMDh to provide corresponding guidance (similar to DR Implementation Plan)

• EU Commission to amend answer to Question 2.3 in the EU Commission’s Q&A document accordingly.

Removal of the linear barcode should be at the MAHs discretion Removal of the linear barcode should be at the MAHs discretion

Encoded data order• International standards define how data in the 2D barcode should be encoded

• Scanning and IT systems do not identify the content e.g. Product Code, based on its position in the encoded data. They use the Application Identifiers which “signpost” the data e.g. 01 = product code, 17 = Expiry date, etc

• Mandating a specific order to encode the data serves no purpose as fields such as batch and serial number vary in length

• Failing to encode data using these standards will lead to scanning systems not being able to read the codes

Mandating a specific order violates International Standards –therefore no specific order should be mandated

Mandating a specific order violates International Standards –therefore no specific order should be mandated

Green = Encoding type used e.g. GS1

Purple = Application Identifiers

Blue = Group Separators

Application identifier use

• Application Identifiers are encoded in the 2D barcode to signpost the data for the IT and scanning systems

• International Standards and good practice recommend they also appear on the human readable text to help if the barcode fails to scan, perhaps due to damage.

• Space and technical constraints can mean that these Application Identifiers can not always be included (which is also considered and allowed by International Standards)

• It should therefore be left to the MAH to determine whether to include the Application Identifiers following International Standards

Application Identifiers in the human readable text should be at the discretion of the MAH, in accordance with International Standards

Application Identifiers in the human readable text should be at the discretion of the MAH, in accordance with International Standards

Printed format of the 2D Data Matrix

• International Standards also allow the 2D barcodes

to be produced in a positive version (black on

white) or a negative version (white on black*)

• Different technologies produce either a positive

or negative image and this will vary across MAHs

• Scanning equipment must be able to read all these

variations according to International Standards

* other dark colours may also be used as long as

there is a high contrast

Square, Rectangular, White & Black 2D barcodes must be accommodatedSquare, Rectangular, White & Black 2D barcodes must be accommodated

• Article 5 of DR states that International Standards

can be used for the 2D barcode format

• International standards allow for the 2D barcodes

to be produced in several different formats e.g.

square and rectangular

Thank you!